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临床试验/CTRI/2021/04/033170
CTRI/2021/04/033170尚未招募不适用

ASSESSMENT OF THE IMPACT OF BODY FAT PERCENTAGE AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT: A PROSPECTIVE CLINICAL STUDY.

SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
EFFECT OF HIGH OR LOW BODY FAT PERCENTAGE AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT

研究概览

简要总结

Orthodontic tooth movement is defined as “theresult of a biologic response to interference in the physiologic equilibrium ofthe dentofacial complex by an externally applied force.†Numerous factors, suchas age, drug consumption, diet, several systemic conditions and other intrinsicgenetic factors are considered to influence the rate of orthodontic toothmovement. Continuous efforts are beingmade to find out the factors influencing orthodontic tooth movement. Body MassIndex (BMI) is one of the factors which is thought to influence orthodontictooth movement. Many studies have been conducted to correlate Body Mass Index(BMI) with orthodontic tooth movement, but the results were either inconclusiveor debatable. This was mainly due to the inappropriate methodologiesapplied in these studies.Another possible reason could be that; inmost of these studies, the Body Mass Index (BMI) was used as a reference todifferentiate normal and obese individuals. Although the Body Mass Index (BMI,kg/m2) is widely used as a proxy measure of adiposity, it is ameasure of excess weight relative to height, rather than excess body fat. Valuesof body weight adjusted to height in square mm is BMI i.e. (BMI; in kg/m2).BMI values in excess of 25 and 30 are considered to indicate overweight andobesity respectively. A BMI value of 18.5 to 24.9 is considered to be normal.The main assumption of BMI guidelines is that body mass divided by height in m2,is closely associated with body fatness. However, some individuals who areoverweight may not be overfat (e.g., bodybuilders). Others have BMI’s withinthe normal range but may have a high percentage of their body weight as fat.Hence the drawbacks of thesestudies were that they only considered BMI as a measure of adiposity todifferentiate between obese and normal individuals and did not consider BodyFat percentage (BF%) levels of the studied individuals.Increase inBody Fat percentage (BF%) levels has been correlated with the increase in serumleptin levels.Studies also have found that the leptin which isavailable in saliva controls bone metabolism which in turn has an inverseeffect on the orthodontic tooth movement.Hence the Body Fatpercentage (BF%) levels could indirectly play a vital role in the orthodontictooth movement. So far in the scientific literature, no studies have beenreported evaluating the relationship of Body Fat percentage (BF%) on orthodontic toothmovement. Hence with the above background, this study is designed to assess therelationship between BMI, Body Fat percentage (BF%) levels and orthodontictooth movement.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • •1.Subjects who are willing to participate in the study.
  • •2.Subjects who will undergo fixed orthodontic treatment with Pre-adjusted Edgewise Appliance (PEA) with 0.022ʺslot MBT prescription.
  • •3.Subjects in the age range of 15-35 years.
  • •4.Normal weight subjects with BMI (18.5Kg/m2 or more and less than 25Kg/m2) and overweight or obese subjects with BMI (25Kg/m2 or more).
  • •5.Subjects with normal Body Fat percentage’s (BF%) 10 to < than 20% for males and 20 to < than 30% for females and high to very high Body Fat percentage’s (BF%) 20% or more for males and 30% or more for females.
  • •6.Subjects who will be entering the retraction stage after completion of the leveling and alignment (Ist phase).
  • •7.Subjects in whom maxillary 1st premolar extraction will be indicated and who will have at least 5mm of space for en masse retraction of maxillary anteriors.

排除标准

  • •1.Previous history of orthodontic treatment.
  • •2.Presence of any syndromes or systemic diseases.
  • •3.Presence of any signs and symptoms of periodontal disease.
  • •4.Long term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs, steroids and calcium channel blockers.
  • •5.Poor oral hygiene for more than 2 visits.
  • •6.Smoking and other habits such as chewing pan.
  • •7.Pregnant and lactating women.
  • •8.Subjects who are on statins or lipid lowering agents.

结局指标

主要结局

EFFECT OF HIGH OR LOW BODY FAT PERCENTAGE AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT

时间窗: THREE MONTHS FROM THE START OF EN MASSE RETRACTION OF MAXILLARY ANTERIOR TEETH

次要结局

  • TO COMPARE THE EFFECT OF BODY FAT PERCENTAGE ON ORTHODONTIC TOOTH MOVEMENT AND BODY MASS INDEX ON ORTHODONTIC TOOTH MOVEMENT(THREE MONTHS FROM THE START OF EN MASSE RETRACTION OF MAXILLARY ANTERIOR TEETH)

研究者

发起方
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL
申办方类型
Research institution and hospital

研究点 (1)

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